Greater Omentum Binding to the Pancreatic Stump to Prevent Pancreatic Fistula Following Distal Pancreatectomy

NCT ID: NCT03752086

Last Updated: 2018-11-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-31
• Study Completion Date: 2021-04-30

Brief Summary

Background and aim: Distal pancreatectomy (DP) is often performed for primary benign or malignant lesions occurred in the body or tail of the pancreas. The occurrence of pancreatic fistula (PF) after DP remains high, ranging from 5% to 60%, despite in high-volume centers. Management of pancreatic stump to prevent PF has been a long-standing issue in pancreatic surgery. Our group has proposed greater omentum binding as a novel approach to secure pancreatic stump with the purpose of reducing PF. With respect to the previous preliminary data which demonstrated greater omentum binding of pancreatic stump significantly reduced the occurrence of PF based on a small prospective cohort, we therefore aimed to verify the safety and effectiveness of this novel approach in a large prospective randomized cohort.

Method: TJBDPS06 is a prospective, randomized controlled, parallel-group, superiority trial in a single high-volume pancreatic center. A total of 200 patients who will receive DP and fulfill the inclusion criteria will be randomly allocated to the greater omentum binding group or the group without this step in an enhanced recovery after surgery (ERAS) setting. The trial hypothesize that greater omentum binding of pancreatic stump could safely and effectively secure pancreatic stump following DP, therefore reducing the occurrence of PF. The primary outcome is PF within 90 days after DP. The secondary outcomes are overall morbidly, mortality, and major complications (Clavien-Dindo ≥III) within 90 days following DP. The duration of entire trial is presumably three years, including prearrangement, two-year inclusion period, and data analysis.

Discussion: The current trial will be the first in demonstrating safety and effectiveness of greater omentum binding of pancreatic stump following DP in a large high-volume pancreatic center. This approach will offer an inexpensive, technically easy, and secure coverage technique for the pancreatic stump in DP and may be particularly useful for patients with a soft pancreas which is a markedly risk factor of PF.

Conditions

Pancreatic Fistula; Pancreatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Greater omentum binding

Bind greater omentum to pancreatic stump after distal pancreatectomy

Group Type: EXPERIMENTAL

greater omentum binding

Intervention Type: PROCEDURE

Bind pancreatic stump using greater omentum after distal pancreatectomy

Pancreatic stump exposed

pancreatic stump exposed without binding greater omentum after distal pancreatectomy

Group Type: EXPERIMENTAL

Pancreatic stump exposed without omentum binding

Intervention Type: PROCEDURE

Pancreatic stump exposed without greater omentum binding after distal pancreatectomy

Interventions

greater omentum binding

Bind pancreatic stump using greater omentum after distal pancreatectomy

Intervention Type: PROCEDURE

Pancreatic stump exposed without omentum binding

Pancreatic stump exposed without greater omentum binding after distal pancreatectomy

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• All patients who undergo DP whether made by open or laparoscopic surgery;
• Patients age 18 to 75 years;
• Patients benefit from distal pancreatectomy according to NCCN guidelines;
• The subject understands the nature of this trial and willing to comply, and ability to provide written informed consent.

Exclusion Criteria

• Distant metastases: peritoneal carcinomatosis, liver metastases, distant lymph node metastases, involvement of other organs;
• History of abdominal disease or surgery which may results in obvious omentum adhesion;
• Synchronous malignancy in other organs;
• Patients with high operative risk as defined by the American Society of Anesthesiologists (ASA) score >4;
• Pregnant women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Renyi Qin

Professor, Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renyi Qin, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Biliary and Pancreatic Surgery, Tongji Hospital

Locations

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Countries

China

Central Contacts

Junfang Zhao

Role: CONTACT

zhaojunfang2012@hotmail.com

+8615827539076

Facility Contacts

Junfang O Zhao, MD, PhD

Role: primary

zhaojunfang2012@hotmail.com

+8615827539076

Other Identifiers

TJDBPS06

Identifier Type: -

Identifier Source: org_study_id